Postoperative Respiratory ComplicationNCT07267897
Nebulized Lidocaine vs 3% Sodium Chloride in Pediatric Adenoid/Tonsil Surgery
A study testing Nebulize Lidocaine and Nebulize %3 Sodium Chloride in people with Postoperative Respiratory Complication, run by Sakarya University.
Trial summary
This prospective, randomized clinical trial aims to evaluate the effect of preoperative nebulized lidocaine and nebulized 3% hypertonic sodium chloride (NaCl) on the incidence of postoperative respiratory complications in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 18 months to 16 years
- Conditions the study is for
- Postoperative Respiratory Complication
- What is being tested?
- Nebulize Lidocaine and Nebulize %3 Sodium Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who agree to participate in the study
- Patients undergoing adenoidectomy or adenotonsillectomy
- Patients with ASA physical status 1-2
- Children aged 18 months to 16 years
Who cannot join
- Patients who do not agree to participate in the study
- Patients with allergy to lidocaine or 3% NaCl
- Patients with ASA physical status 3-4
- Patients whose surgery duration exceeds 1 hour
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Preoperative Nebulized Lidocaine and Nebulized 3% NaCl Premedication on Postoperative Respiratory Complications in Pediatric Patients Undergoing Adenoidectomy and/or Adenotonsillectomy Surgery
This prospective, randomized clinical trial aims to evaluate the effect of preoperative nebulized lidocaine and nebulized 3% hypertonic sodium chloride (NaCl) on the incidence of postoperative respiratory complications in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. Lidocaine, a versatile sodium channel blocker, has shown antitussive, bronchodilatory, and anti-inflammatory benefits when nebulized, and has been safely used in children for respiratory procedures. Hypertonic 3% NaCl is known to improve mucociliary clearance, reduce airway edema, and enhance secretion mobilization, particularly in pediatric respiratory conditions. Both agents have demonstrated individual safety and efficacy in respiratory management, yet their preoperative nebulized use for preventing postoperative respiratory adverse events (PRAEs) in pediatric airway surgery has not been previously studied. This trial seeks to determine whether preoperative nebulization with these agents can reduce postoperative respiratory complications, improve recovery, and enhance perioperative safety in this high-risk population.
Read the detailed description
Lidocaine is a drug with multiple clinical uses. Beyond its classical indication as a sodium channel blocker in local, regional, and neuraxial anesthesia, it has been:
- administered intravenously as an antitussive agent in ophthalmic surgery,
- used in both human and veterinary anesthesia to reduce the minimum alveolar concentration (MAC),
- applied as an analgesic for acute pain,
- used as an antiarrhythmic for ventricular arrhythmias,
- administered as a cardioplegic agent in cardiac surgery,
- used as a local anesthetic for venous cannulation,
- nebulized during awake airway interventions,
- nebulized in refractory cough, and
- applied into the endotracheal tube cuff to prevent postoperative sore throat.
Nebulized lidocaine has previously been used in adults with chronic obstructive pulmonary disease, acute asthma, and acute lung infections to suppress cough and provide bronchodilation, and has been found safe and effective. High doses (up to 8 mg/kg) of nebulized lidocaine have been safely administered in infants and children prior to flexible bronchoscopy to reduce perioperative respiratory adverse events (PRAEs).
Hypertonic 3% sodium chloride (NaCl) solution is an agent that has been extensively studied and used clinically in respiratory diseases. Its primary mechanisms of action include osmotic rehydration of the airway surface liquid, thinning mucus, and facilitating mucociliary clearance. This reduces secretion viscosity and supports easier mucus removal. It may also reduce airway edema, relieve obstruction, and promote the dissolution of mucus plugs. Some studies suggest it may exert anti-inflammatory effects by limiting inflammatory mediators. In clinical practice, it has been shown to be safe and effective in children with acute bronchiolitis, reducing hospital stay and improving symptoms. In addition, it is used in cystic fibrosis, chronic bronchitis, COPD, and acute pulmonary infections to enhance mucus clearance and improve respiratory function.
Adenoidectomy and tonsillectomy are among the most common surgical procedures performed in the pediatric population, primarily due to recurrent throat infections and sleep-disordered breathing associated with obstructive sleep apnea. Postoperative complications may include bleeding, respiratory distress, airway obstruction, postoperative pain, and dehydration. Reported respiratory complication rates range from 2% to 4%, rising to 13-15% in high-risk groups. Beyond the inherent respiratory risks of the surgery itself, perioperative respiratory adverse events (PRAEs) are highly prevalent in pediatric patients. These include minor events (oxygen desaturation, airway obstruction, cough, or wheezing) and major events (laryngospasm and bronchospasm). Such complications may prolong hospitalization, increase healthcare costs, and cause varying degrees of physical and psychological stress in both children and their caregivers. PRAEs are documented in up to 50% of children undergoing tonsillectomy.
Certain studies in the literature have investigated preoperative premedication strategies to reduce the incidence of postoperative respiratory adverse events. However, our literature review revealed no studies evaluating the postoperative beneficial effects of the preoperative nebulized use of the agents planned in our study. Based on this gap, we designed this study with the aim of contributing new data to the current literature.
- Conditions
- Postoperative Respiratory Complication
- Being tested
- Nebulize Lidocaine, Nebulize %3 Sodium Chloride
- Keywords
- Postoperative Respiratory Complication, Lidocaine, %3 Sodium Chloride, Pediatric, Adenoidectomy, Adenotonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulize LidocaineDrug
Also called Lidocaine
Preoperative administration of lidocaine via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications.
Nebulize %3 Sodium ChlorideDrug
Also called %3 NaCl
Preoperative administration of 3% hypertonic saline via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications.
| Study group | Role | What they receive |
|---|---|---|
| Grup L | Experimental | Patients will receive 0.2 ml/kg of nebulized lidocaine under monitoring, with the treatment completed 15 minutes prior to the surgical procedure. Receives: Drug: Nebulize Lidocaine |
| Grup H | Experimental | Patients will receive 0.2 ml/kg of nebulized %3 hypertonic saline under monitoring, with the treatment completed 15 minutes prior to the surgical procedure.. Receives: Drug: Nebulize %3 Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on postoperative deoxygenation
To determine which preoperative nebulized treatment (lidocaine or 3% hypertonic saline) has a beneficial effect on at least one postoperative respiratory complication-postoperative deoxygenation in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. An oxygen saturation value of ≤94% lasting for more than 2 minutes will be considered oxygen desaturation.
Measured: 4 hours postoperatively
Secondary outcomes (2)
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on cough
To determine which preoperative nebulized treatment (lidocaine or 3% hypertonic saline) has a beneficial effect on at least one postoperative respiratory complication-cough in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. Postoperative cough will be assessed using a 4-point cough severity scale (0 = no cough, 1 = mild intermittent cough, 2 = frequent cough, 3 = severe or persistent cough). A score ≥2 will be considered clinically significant.
Measured: 4 hours postoperatively
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on bronkospasm
To determine which preoperative nebulized treatment (lidocaine or 3% hypertonic saline) has a beneficial effect on at least one postoperative respiratory complication-bronkospasm in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. Bronchospasm will be assessed using a 4-point bronchospasm severity scale: 0 = no bronchospasm; 1 = mild wheezing without increased respiratory effort; 2 = moderate bronchospasm with increased respiratory effort and audible wheezing; 3 = severe bronchospasm with marked respiratory distress, significant desaturation, or silent chest. A score ≥2 will be considered clinically significant.
Measured: 4 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Mar 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Respiratory ComplicationStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment design in which pediatric patients undergoing adenoidectomy and/or adenotonsillectomy are randomly assigned to one of the intervention groups. Each participant will receive only one type of preoperative nebulized treatment (lidocaine, 3% hypertonic saline, or control), and outcomes will be compared between the groups throughout the study period.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Alaçam, MD, Sakarya University
- Investigators
- Burçin Alaçam, MD, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267897
- Sponsor's protocol ID
- SAU-ANE-BA-01
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shen F, Zhang Q, Xu Y, Wang X, Xia J, Chen C, Liu H, Zhang Y. Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225473. doi: 10.1001/jamanetworkopen.2022.25473.
PubMed 35943745Jarraya A, Kammoun M, Cherif O, Khcherem J, Abdelhedi A, Mhiri R. Preoperative nebulised lidocaine for children with mild symptoms of upper respiratory tract infections: A randomised controlled trial. J Perioper Pract. 2025 Jun;35(6):278-284. doi: 10.1177/17504589241276651. Epub 2024 Sep 18.
PubMed 40396523
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Nebulized Lidocaine and Nebulized 3% NaCl Premedication on Postoperative Respiratory Complications in Pediatric Patients Undergoing Adenoidectomy and/or Adenotonsillectomy Surgery
- ClinicalTrials.gov ID
- NCT07267897
- Acronym / sponsor ID
- SAU-ANE-BA-01
- Conditions
- Postoperative Respiratory Complication
- Keywords
- Postoperative Respiratory Complication, Lidocaine, %3 Sodium Chloride, Pediatric, Adenoidectomy, Adenotonsillectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized clinical trial aims to evaluate the effect of preoperative nebulized lidocaine and nebulized 3% hypertonic sodium chloride (NaCl) on the incidence of postoperative respiratory complications in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. Lidocaine, a versatile sodium channel blocker, has shown antitussive, bronchodilatory, and anti-inflammatory benefits when nebulized, and has been safely used in children for respiratory procedures. Hypertonic 3% NaCl is known to improve mucociliary clearance, reduce airway edema, and enhance secretion mobilization, particularly in pediatric respiratory conditions. Both agents have demonstrated individual safety and efficacy in respiratory management, yet their preoperative nebulized use for preventing postoperative respiratory adverse events (PRAEs) in pediatric airway surgery has not been previously studied. This trial seeks to determine whether preoperative nebulization with these agents can reduce postoperative respiratory complications, improve recovery, and enhance perioperative safety in this high-risk population.
Detailed description
Lidocaine is a drug with multiple clinical uses. Beyond its classical indication as a sodium channel blocker in local, regional, and neuraxial anesthesia, it has been:
- administered intravenously as an antitussive agent in ophthalmic surgery,
- used in both human and veterinary anesthesia to reduce the minimum alveolar concentration (MAC),
- applied as an analgesic for acute pain,
- used as an antiarrhythmic for ventricular arrhythmias,
- administered as a cardioplegic agent in cardiac surgery,
- used as a local anesthetic for venous cannulation,
- nebulized during awake airway interventions,
- nebulized in refractory cough, and
- applied into the endotracheal tube cuff to prevent postoperative sore throat.
Nebulized lidocaine has previously been used in adults with chronic obstructive pulmonary disease, acute asthma, and acute lung infections to suppress cough and provide bronchodilation, and has been found safe and effective. High doses (up to 8 mg/kg) of nebulized lidocaine have been safely administered in infants and children prior to flexible bronchoscopy to reduce perioperative respiratory adverse events (PRAEs).
Hypertonic 3% sodium chloride (NaCl) solution is an agent that has been extensively studied and used clinically in respiratory diseases. Its primary mechanisms of action include osmotic rehydration of the airway surface liquid, thinning mucus, and facilitating mucociliary clearance. This reduces secretion viscosity and supports easier mucus removal. It may also reduce airway edema, relieve obstruction, and promote the dissolution of mucus plugs. Some studies suggest it may exert anti-inflammatory effects by limiting inflammatory mediators. In clinical practice, it has been shown to be safe and effective in children with acute bronchiolitis, reducing hospital stay and improving symptoms. In addition, it is used in cystic fibrosis, chronic bronchitis, COPD, and acute pulmonary infections to enhance mucus clearance and improve respiratory function.
Adenoidectomy and tonsillectomy are among the most common surgical procedures performed in the pediatric population, primarily due to recurrent throat infections and sleep-disordered breathing associated with obstructive sleep apnea. Postoperative complications may include bleeding, respiratory distress, airway obstruction, postoperative pain, and dehydration. Reported respiratory complication rates range from 2% to 4%, rising to 13-15% in high-risk groups. Beyond the inherent respiratory risks of the surgery itself, perioperative respiratory adverse events (PRAEs) are highly prevalent in pediatric patients. These include minor events (oxygen desaturation, airway obstruction, cough, or wheezing) and major events (laryngospasm and bronchospasm). Such complications may prolong hospitalization, increase healthcare costs, and cause varying degrees of physical and psychological stress in both children and their caregivers. PRAEs are documented in up to 50% of children undergoing tonsillectomy.
Certain studies in the literature have investigated preoperative premedication strategies to reduce the incidence of postoperative respiratory adverse events. However, our literature review revealed no studies evaluating the postoperative beneficial effects of the preoperative nebulized use of the agents planned in our study. Based on this gap, we designed this study with the aim of contributing new data to the current literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment design in which pediatric patients undergoing adenoidectomy and/or adenotonsillectomy are randomly assigned to one of the intervention groups. Each participant will receive only one type of preoperative nebulized treatment (lidocaine, 3% hypertonic saline, or control), and outcomes will be compared between the groups throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Grup L | Experimental | Drug: Nebulize LidocainePatients will receive 0.2 ml/kg of nebulized lidocaine under monitoring, with the treatment completed 15 minutes prior to the surgical procedure. |
| Grup H | Experimental | Drug: Nebulize %3 Sodium ChloridePatients will receive 0.2 ml/kg of nebulized %3 hypertonic saline under monitoring, with the treatment completed 15 minutes prior to the surgical procedure.. |
Who may qualify
- Ages
- 18 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients who agree to participate in the study
- Patients undergoing adenoidectomy or adenotonsillectomy
- Patients with ASA physical status 1-2
- Children aged 18 months to 16 years
Key exclusion criteria (4 listed)
- Patients who do not agree to participate in the study
- Patients with allergy to lidocaine or 3% NaCl
- Patients with ASA physical status 3-4
- Patients whose surgery duration exceeds 1 hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulize LidocaineAlso: LidocainePreoperative administration of lidocaine via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications. | Drug | Grup L |
| Nebulize %3 Sodium ChlorideAlso: %3 NaClPreoperative administration of 3% hypertonic saline via nebulization at 0.2 ml/kg to reduce postoperative respiratory complications. | Drug | Grup H |
Primary outcome
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on postoperative deoxygenation
Time frame: 4 hours postoperatively
To determine which preoperative nebulized treatment (lidocaine or 3% hypertonic saline) has a beneficial effect on at least one postoperative respiratory complication-postoperative deoxygenation in pediatric patients undergoing adenoidectomy and/or adenotonsillectomy. An oxygen saturation value of ≤94% lasting for more than 2 minutes will be considered oxygen desaturation.
2 secondary outcomes
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on cough
Time frame: 4 hours postoperatively
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on bronkospasm
Time frame: 4 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 35943745Shen F, Zhang Q, Xu Y, Wang X, Xia J, Chen C, Liu H, Zhang Y. Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225473. doi: 10.1001/jamanetworkopen.2022.25473.
- Background: PubMed 40396523Jarraya A, Kammoun M, Cherif O, Khcherem J, Abdelhedi A, Mhiri R. Preoperative nebulised lidocaine for children with mild symptoms of upper respiratory tract infections: A randomised controlled trial. J Perioper Pract. 2025 Jun;35(6):278-284. doi: 10.1177/17504589241276651. Epub 2024 Sep 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Burçin Alaçam, MD principal investigator
Sakarya University
Questions about this trial
What is this clinical trial studying?
A study testing Nebulize Lidocaine and Nebulize %3 Sodium Chloride in people with Postoperative Respiratory Complication, run by Sakarya University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burçin Alaçam, MD (+905465903851, burcin.ersoy90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Preoperative Nebulized Lidocaine and 3% NaCl on postoperative deoxygenation (time frame: 4 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07267897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.